Medical devices are categorized into three classes according to the degree of product risk.
The first category includes routine culture media, medical stains, dilutions, etc.;
The third category includes antigen and antibody of disease-causing pathogens, nucleic acid test reagents, tumor marker test reagents, allergen test reagents, psychotropic drugs, drugs, narcotic drug test reagents and other high-risk items of medical items;
The products other than those in the first category and the third category belong to the third category. The second category, including enzymes, hormones, sugars and conventional drug metabolism testing items.